GLOBAL Regulatory Writing & Consulting provides an extensive array of consulting, writing, and eCTD publishing services tailored for Sponsors and CDMOs in the pharmaceutical industry. With a team of world-class scientists and regulatory experts, the company offers guidance throughout the product lifecycle, from inception to bedside. They navigate the myriad technical, quality, and regulatory development hurdles, utilising their expertise in health authority requirements, technical acumen, and industry best practices to produce technical and regulatory documents that meet agency expectations and are scientifically robust.

Services include:
- 505(b)(2)
- Analytical Services
- Assay Development
- Auditing
- Bioanalytical Services
- Process Development
- Bioprocess Validation
- Bioprocessing
- Biosimilars
- Chemistry (CMC)
- Manufacturing
- Consulting
- Process Analytical Technology (PAT)
- Process Excellence
- Quality Management Systems
- Records Management
- Regulatory
- Talent Acquisition
- Custom Manufacturing
- DMF Establishment / Maintenance
- Documentation Support Services
- Drug Development
- IND/NDA Submissions
- Process Characterization
- Process Validation Studies
- Project Management
- Quality QA/QC
- Regulatory Affairs Consultants
- Scale-Up
- Technology Transfer
- Training
- Validation

GLOBAL Regulatory Writing & Consulting is committed to delivering unparalleled support and expertise in the pharmaceutical development process. For more information, visit globalrwc.com.